Bright Light Therapy in ME/CFS Patients (BLTME)

October 9, 2024 updated by: Stefan Seidel, Medical University of Vienna

Assessing Fatigue and Attention in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients Before and After Treatment With Bright Light Therapy: a Prospective Randomized Controlled Crossover Study

In this study patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) will receive bright light therapy through portable lamps for 2 weeks. They will either start with this treatment and then go through a wash-out period of two weeks followed by a wait period of two weeks or they will start with the wait period, followed by a wash-out period, followed by the treatment phase. Patients are asked to fill out questionnaires (rating their level of fatigue) and they go through a standardized computer test assessing their attention levels, both at multiple times throughout the study. The aim of this study is to find out if treatment with bright light will improve subjective fatigue levels and objective attention levels inME/CFS patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic Fatigue Syndrome (CFS), also referred to as Myalgic Encephalomyelitis (ME), is a chronic, debilitating condition of unknown etiology. Bright light therapy (BLT) has shown promising results in studies investigating its effect in patients with neurological disorders experiencing fatigue symptoms (Mateen et al., 2020, Sinclair et al., 2014, West et al., 2019). Since effective and low to no side effect therapies are duly needed for the treatment of ME/CFS, we propose a randomized-controlled treatment approach with bright light therapy (BLT).

In this proposed study, a total of 38 out-patients with a diagnosis of ME/CFS according to the criteria of the Institute of Medicine will be randomly assigned to a crossover design starting out either with BLT or being waitlisted for the course of two weeks. Portable light boxes emitting full-spectrum visible light with a luminance intensity of 10,000 lux measured at a distance of 50 cm will be used at the participants' home for 2 weeks.

Primary outcome of the study will be the level of fatigue before and after treatment as operationalized by the Chalder Fatigue Score. Secondary outcomes include the objective activity pattern as measured by actigraphy as well as cognitive and metacognitive functioning assessed before and after treatment.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of ME/CFS according to the IOM (IOM, 2015)
  • Chalder Fatigue Score of ≥ 18 points (Likert scoring)
  • age 18-60 years;
  • ability to give informed consent.

Exclusion Criteria:

  • Comorbidities explaining current fatigue symptoms such as sleep-wake disorders (narcolepsy, sleep apnea, periodic limb movements during sleep and irregular sleep-wake-rhythm), untreated hypothyroidism and iatrogenic conditions such as side effects of medication.
  • Previous treatment with BLT (> 10.000 lux) for a duration of >2 weeks.
  • Previously diagnosed medical conditions such as malignancies and hepatitis B or C virus infection.
  • Any past or current diagnosis of bipolar affective disorder; schizophrenia; dementias of any subtype; anorexia nervosa; or bulimia nervosa.
  • Alcohol or other substance abuse disorders within 2 years before the onset of the chronic fatigue and at any time afterward.
  • Severe obesity as defined by a body mass index equal to or greater than 45.
  • Medication use interacting with the circadian rhythm such as regular intake of sleeping pills, sleep-inducing antidepressant medication, and immunosuppressive medication.
  • >20 points in the HDRS-17
  • >10 points in GAD-7 in the psychiatric screening process
  • Pregnancy
  • Change in regimen of ongoing treatment with antidepressants or stimulants within 4 weeks before study inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Wait list
Experimental: Intervention
Bright light therapy for 2 weeks, 30min a day
Device: Bright light therapy
30min daily of 10.000 lux bright light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chalder Fatigue Score
Time Frame: As a baseline variable: day 1 of inclusion in the study, day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list
subjective Fatigue score
As a baseline variable: day 1 of inclusion in the study, day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test of Attentional Performance
Time Frame: On day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list
three subtests of attention
On day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

March 25, 2024

Study Completion (Actual)

March 25, 2024

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUVienna

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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